Pharmacovigilance: post-authorisation

European Union (EU) legislation requires marketing authorisation holders, national competent authorities and the European Medicines Agency (EMA) to follow a number of pharmacovigilance processes after a product has been authorised.

Monitoring the safety of a medicine once it is on the market is the cornerstone of pharmacovigilance. 

EMA provides extensive guidance to enable all stakeholders to meet their legal pharmacovigilance obligations.

In this section

• Direct healthcare professional communications
• European Risk Management Strategy (ERMS)
• Good pharmacovigilance practices (GVP)
• Incident management plan
• Medical literature monitoring
• Medication errors
• Medicines under additional monitoring
• Periodic safety update reports (PSURs)
• Pharmacovigilance systems
• Post-authorisation safety studies (PASS)
• Regulatory and procedural guidance
• Risk management plan (RMP)
• Signal management

In other sections

Marketing authorisation holders should also consider the regulatory information in the sections below:

• EudraVigilance
• Patient registries
• Pharmacovigilance fees
• Pharmacovigilance inspections
• Post-authorisation safety studies: questions and answers
• Risk management